Company: Philips Healthcare Informatics, Inc.
Date of Enforcement Report: 6/17/2020
Class II
PRODUCT
IntelliSpace PACS 4.4, Product number 837507 – Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
Recall Number: Z-2338-2020
REASON
Images may potentially become corrupt while using the system.
RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc. on 4/19/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
U.S. Nationwide and International